Novel Influenza A/H1N1NCT01289418
Surveillance for Adverse Events Following Pandemic H1N1 Immunization
An observational study of Novel Influenza A/H1N1, run by PHAC/CIHR Influenza Research Network.
Trial summary
Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or with oculorespiratory syndrome (2001). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Novel Influenza A/H1N1
- How many people
- 6,525 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to May 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The active surveillance was conducted in three Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.
Who may be able to join
- To be a health care worker from one of the three Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax.
- To have been immunized with the pH1N1 vaccine.
- To have an email address.
- To be 18 years old and older.
Who cannot join
- -
About this study
Official title: Short and Long-Term Electronic Surveillance of a Large Number of Healthcare Workers Following Administration of an Adjuvanted Ph1n1 Vaccine
Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine. While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000 people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical trials before the mass campaign was launched. With this small number, adverse events occurring at a rate < 1% will not be detected by these clinical trials.
Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive surveillance is collecting notifications of adverse events but the sensitivity of this system is not high and its timeliness is not necessarily optimal.
Read more
In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine in priority. Because they were offered the vaccine early in the campaign and because they constitute a well-defined group in good general health, this group of people may be well suited for monitoring the safety of the pH1N1 vaccine.
The main objective of this project was to estimate in HCW vaccinated against pH1N1 the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.
The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City (Quebec): 3 hospitals, (3) Toronto
- Conditions
- Novel Influenza A/H1N1
- Keywords
- H1N1, vaccine safety, adverse events, health care workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health care workers in Québec | Health care workers from CHUQ hospitals | |
| Health care workers in Toronto | Health care workers from the Mount Sinai Hospital | |
| Health care workers in Halifax | Health care workers from the Queen Elizabeth Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.
Measured: at day 8, 15 and 29
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
Measured: day 8, 15 and 29
the Occurrence of Serious Adverse Events (SAE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Novel Influenza A/H1N1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHAC/CIHR Influenza Research Network
- Sponsor type
- Other government
- Collaborators
- GlaxoSmithKline, Institut National en Santé Publique du Québec, Laval University, CHU de Quebec-Universite Laval, Queen Elizabeth II Health Sciences Centre, Mount Sinai Hospital, New York, The Ottawa Hospital, Hamilton Health Sciences Corporation, Alberta Children's Hospital, Vancouver General Hospital
- Responsible party
- Principal investigator, Gaston De Serres, Laval University
- Investigators
- Gaston De Serres, MD, PhD, Principal investigator, Institut National en Santé Publique du Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289418
- Sponsor's protocol ID
- pcirn-surveillancehcw-0910
- Status last verified
- Aug 2012
- First submitted
- 2 Feb 2011
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
De Serres G, Gariepy MC, Coleman B, Rouleau I, McNeil S, Benoit M, McGeer A, Ambrose A, Needham J, Bergeron C, Grenier C, Sleigh K, Kallos A, Ouakki M, Ouhoummane N, Stiver G, Valiquette L, McCarthy A, Bettinger J; PHAC-CIHR influenza Research Network (PCIRN). Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine. PLoS One. 2012;7(7):e38563. doi: 10.1371/journal.pone.0038563. Epub 2012 Jul 3.
PubMed 22802929
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-Term Electronic Surveillance of a Large Number of Healthcare Workers Following Administration of an Adjuvanted Ph1n1 Vaccine
- ClinicalTrials.gov ID
- NCT01289418
- Acronym / sponsor ID
- pcirn-surveillancehcw-0910
- Conditions
- Novel Influenza A/H1N1
- Keywords
- H1N1, vaccine safety, adverse events, health care workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,525 participants (actual)
- Lead sponsor
- PHAC/CIHR Influenza Research NetworkOther government
- Collaborators
- GlaxoSmithKline, Institut National en Santé Publique du Québec, Laval University, CHU de Quebec-Universite Laval, Queen Elizabeth II Health Sciences Centre, Mount Sinai Hospital, New York, The Ottawa Hospital, Hamilton Health Sciences Corporation, Alberta Children's Hospital, Vancouver General Hospital
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine. While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000 people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical trials before the mass campaign was launched. With this small number, adverse events occurring at a rate < 1% will not be detected by these clinical trials.
Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive surveillance is collecting notifications of adverse events but the sensitivity of this system is not high and its timeliness is not necessarily optimal.
In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine in priority. Because they were offered the vaccine early in the campaign and because they constitute a well-defined group in good general health, this group of people may be well suited for monitoring the safety of the pH1N1 vaccine.
The main objective of this project was to estimate in HCW vaccinated against pH1N1 the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.
The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City (Quebec): 3 hospitals, (3) Toronto
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health care workers in Québec | – | –Health care workers from CHUQ hospitals |
| Health care workers in Toronto | – | –Health care workers from the Mount Sinai Hospital |
| Health care workers in Halifax | – | –Health care workers from the Queen Elizabeth Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The active surveillance was conducted in three Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.
Key inclusion criteria (4 listed)
- To be a health care worker from one of the three Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax.
- To have been immunized with the pH1N1 vaccine.
- To have an email address.
- To be 18 years old and older.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.
Time frame: at day 8, 15 and 29
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
Time frame: day 8, 15 and 29
the Occurrence of Serious Adverse Events (SAE)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22802929De Serres G, Gariepy MC, Coleman B, Rouleau I, McNeil S, Benoit M, McGeer A, Ambrose A, Needham J, Bergeron C, Grenier C, Sleigh K, Kallos A, Ouakki M, Ouhoummane N, Stiver G, Valiquette L, McCarthy A, Bettinger J; PHAC-CIHR influenza Research Network (PCIRN). Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine. PLoS One. 2012;7(7):e38563. doi: 10.1371/journal.pone.0038563. Epub 2012 Jul 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaston De Serres, MD, PhD principal investigator
Institut National en Santé Publique du Québec
Questions about this trial
What is this clinical trial studying?
An observational study of Novel Influenza A/H1N1, run by PHAC/CIHR Influenza Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation. (time frame: at day 8, 15 and 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.